NCT05070520 is a Phase 4 clinical trial of Artemether-lumefantrine in MALARIA, sponsored by Programme National de Lutte contre le Paludisme, Niger.

Who is sponsoring NCT05070520?

NCT05070520 is sponsored by Programme National de Lutte contre le Paludisme, Niger.

What drugs are being tested in NCT05070520?

Interventions in NCT05070520: Artemether-lumefantrine.

Is NCT05070520 still recruiting?

NCT05070520 is currently completed. Last updated 7 October 2021.

Last reviewed 2021-10-07 · How we verify

NCT05070520

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy of Antimalarial Drugs Used for the Treatment of Uncomplicated Malaria, Plasmodium Falciparum, at the Agadez, Gaya and Tessaoua Sentinel Sites

Completed Phase 4 Last updated 7 October 2021

What this trial tests

Phase 4 trial testing Artemether-lumefantrine in MALARIA in 259 participants. Completed in 28 October 2020.

Timeline

1 September 2020

Primary endpoint
30 September 2020

28 October 2020

Quick facts

Lead sponsor	Programme National de Lutte contre le Paludisme, Niger
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	single
Primary purpose	treatment
Enrollment	259
Start date	1 September 2020
Primary completion	30 September 2020
Estimated completion	28 October 2020
Sites	1 location across Niger

Drugs / interventions tested

Artemether-lumefantrine

Conditions studied

MALARIA — all drugs for MALARIA →

Sponsor

Programme National de Lutte contre le Paludisme, Niger

Who can join

Adults 3 Months to 15, any sex, with MALARIA. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In Niger, malaria is a major public health problem. It is the main cause of morbidity and mortality among children. The management of malaria cases is based on the principle of early diagnosis and rapid treatment with effective drugs. It is confronted with the appearance of strains resistant to antimalarial drugs, hence the need to monitor antimalarial drug sensitivity. The study was conducted in three regions representing epidemiological strata of the country: Agadez (Centre de santé Intégré of Dagamanet in the Health district of Agadez), Maradi (Centre de santé intégré of Guindaoua in Tessaoua) and Dosso (Centre de santé Intégré centre in Gaya). The protocol used is the WHO standardized protocol of 2009. Artemether/Lumefantrine (AL) was administered with a 28-day follow-up in children aged 3 months to 15 years. A Polymerase Chain Reaction (PCR) correction is planned to differentiate between treatment failure and re-infestation as well as a study of genes responsible for resistance on the main drugs used.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Therapeutic efficacy and tolerability of artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria in Niger, 2020.
Laminou IM, Issa I, Adehossi E, Maman K, et al · · 2024 · cited 3× · PMID 38741101 · DOI 10.1186/s12936-024-04945-8
Therapeutic Efficacy and Tolerability of Artemether-lumefantrine for Uncomplicated Plasmodium Falciparum Malaria in Niger, 2020
LAMINOU IM, ARZIKA I, ADEHOSSI E, MAMAN K, et al · · 2024 · DOI 10.21203/rs.3.rs-3851664/v1

Verify or expand the search:

Other trials of Artemether-lumefantrine

Trials testing the same drug.

NCT06076213 — Test Efficacy Study on the Recommended Antimalarial Drugs in the Democratic Republic of the Congo · Phase 4 · completed
NCT05764746 — Triple Artemisinin-based Combination Therapy for Delaying Drug Resistance Development - a Randomized Clinical Trial · Phase 2, PHASE3 · recruiting
NCT05676645 — Pharmacokinetics of Antimalarials in Breastfeeding Ugandan Mother-infant Pairs · active not recruiting
NCT04080895 — Pharmacokinetic Study of Artemether-lumefantrine and Amodiaquine in Healthy Subjects · Phase 1 · terminated
NCT05550909 — Gametocytocidal and Transmission-blocking Efficacy of ASAQ and ALAQ With or Without PQ in Mali · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05070520 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Programme National de Lutte contre le Paludisme, Niger
Last refreshed: 7 October 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05070520.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing